Lines and Plants for Pharmaceutical Purposes
Mphatlalatsane engineering team focuses mostly on fluid drugs sterile production processes. A full understanding of the drug production process is the key concept for correct design. Clear definition, assessment, monitoring of critical parameters directly affecting product quality are the baseline for the application of suitable Process Analytical Technologies granting both complete in-line and at-line quality control. Every process follows rigorous c GMP- compliant Standard Operating Procedures. Specification, construction, verification steps within the project lifecycle follow GAMP “V” models, considering Risk Assessment, architecture of system components, functional specification, sanitization, sterilization and validation issues with special overview to a sustainable maintenance of the system.
Our Mphatlalatsane work breakdown structure consisting in following activities:Design (quality by design)
- Construction (mechanicals, electro-pneumatics, software)
- Testing
- Documentation
- Installation
- Validation
- Start up
A complete technical documentation is part of our equipment and includes:
- General Documentation and Constructive Specification
- Components Documentation
- Valves Documentation Instruments Documentation
- Electrical/pneumatic Documentation
- Hardware and Software Documentation
- Piping, Fitting and Welding Documentation
- Non-destructive test certificate
- Operating and Maintenance Instructions
- Spare Parts
Mphatlalatsane involves its proven experience in three ranges of pharmaceutical equipment:
Water Treatment Systems
Mphatlalatsane pharmaceutical water treatment systems are designed to produce compendial (USP , Pharmacopeia standard)
- PW - Purified Water
- HPW - Highly Purified Water
- WFI - Water For Injection
- PS - Pure Steam
Pre-treatment options, monitoring of critical parameters, regulatory requirement for product quality, consumptions, microbiological control, operation and maintenance requirements, lifecycle costs are key points in our design of all processing steps, from feed water to the point of use. Special care is giv en to the choice of sanitary materials. Product-contact surfaces are in certified AISI 316L stainless steel, with standard roughness < 0.4 µm. EPDM or PTFE gaskets ensure perfect sealing. Advanced Process Analytical Technologies are applied for monitoring issues and professional GAMP compliant automation is provided for system control.
Processing Systems
Mphatlalatsane designs, manufactures and installs complete Formulation & Preparation Plants starting from specific Product and User Requirements. Sterile preparation or cleaning and steriliza tion of process vessels or contact equipment are common issues in the pharmaceutical industry and therefore a must in any of our projects. Specific manufacturing of solutions or sanitization & sterili zation requirements can be satisfied by our processing systems, providing the optimum balance of performance with cost effective aseptic processing equipment through Mphatlalatsane solutions including
Mixing Tanks And Bioreactors:
- Mixing Vessels
- Pressure Tanks/ Pressure Vessels
- Reactors Vessels
- Customized Formulation Tanks
- Mobile Mixing Vessels
- Atmospheric Transfer Tanks
Cip/Sip Systems
- Customized Stations
- Mobile Stations
Pipes Fabrications
Mphatlalatsane also specialized on pipes fabrications using stainless steel 316L for pharmaceuti- cal industries including the contractions of media transfer facility / infrastructure including but not limited purified water loop systems, Heat exchangers, Filters, pumps.